Authors


Yudong Zhao, PhD

Latest:

Harnessing the Power of Scientific Surveillance

Statistical methods used via this technique in centralized monitoring.


Kevin T. Fielman, PhD

Latest:

Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches

Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.



Scott Scarola

Latest:

Orchestrating Different Levels of a Successful Clinical Study Start-Up

Similar to a world-class symphony, a curated site start-up model can accentuate its individual components and lead to swift starts for clinical trials.



Olivier Lantrès

Latest:

COVID-19: A New Era for Clinical Trial Research in Europe?

A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.


Ally Hochman

Latest:

Implementing ePROs in Arthritis Clinical Research

The value of electronic patient-reported outcomes data in this disease setting.



Goonaseelan (Colin) Pillai

Latest:

Africa is Biosimulation’s Next Frontier

The answers to meeting biosimulation's growing demand for talent may lie in Africa.


Aman Khera

Latest:

Using Digital Technology to Empower Patients and Restore Trust

Looking at the road ahead to properly utilizing digital technology in clinical trials.


Tina Caruana

Latest:

The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations

Tufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.


Deepika Khedekar

Latest:

COPD: Therapies on the Cusp

Clinical trials in this area reflect new science, and corresponding challenges in their execution.


Jess Ross, PhD

Latest:

Beyond the Black Box: Tailoring AI Regulation in Healthcare

As adoption increases, regulatory bodies are becoming more involved in the oversight of artificial intelligence.


Peter M. O’Neill

Latest:

A Digital Twin on CAR-T Cytokine Release Syndrome (CRS) Patients with Standard of Care Measured by CRS Distribution by Grade

Using existing clinical trial data to proactively model patient safety and efficacy outcomes could aid in accelerating development for areas in need of new therapies.


Amy Raymond, PhD, PMP

Latest:

Evolving Tools and Perspectives for the Development of Cell and Gene Therapies

Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.



Caroline Keane

Latest:

Self-collection of Blood Specimens in Clinical Trials

Operational and patient burden considerations for self-collection of blood specimens in clinical trials


Pat Larrabee

Latest:

Sites Still Necessary for Decentralized Trials

Has technology taken the industry too far?



Sanjeev Luther

Latest:

Cancer Won’t Wait for COVID to End: Conducting Trials Amid the Coronavirus Pandemic

Thousands of trials have been halted as a consequence of the coronavirus pandemic, slowing the pace of scientific progress dramatically.


Don Lazas

Latest:

5 Reasons Physicians Should Integrate Clinical Trials Into Their Practice

Using IROs can offer the opportunity for doctors to incorporate clinical research as a care option in their practices.


Scott Gray

Latest:

Streamlining Clinical Trials: Mitigation and Management

How service providers are helping to accelerate drug development.


John Corcoran

Latest:

At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ Device

Laboratory services organization focuses on easing patient and site burden with improved collection device.


Devin Solanki

Latest:

From Quality by Constraint to Quality and Choice

How management of trials must evolve.


Ralph Passarella

Latest:

What Do COVID-19 Vaccine Timelines Mean For Clinical Development?

The pandemic spurred an urgency to innovate that improved clinical development in ways that should benefit the industry beyond COVID-19.


Herman Pieterse

Latest:

Towards a Global Implementation of eConsent in Clinical Trials

All stakeholders must play part in increasing implementation.


Jennifer Visser-Rogers

Latest:

Creating Strategic Relationships: The Changing Face of Contract Research Organizations and Sponsor Partnerships

By taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.


Shaena Kauffman

Latest:

Helping Rescued Adjudication Committees Get Back on Track

Determining if an EAC is at risk and key actions to mitigate trial impact.


Matt Simmons

Latest:

Where Innovation and Patients Meet to Improve Cancer Care

Promising scientific advances are pacing oncology drug development.


Kevin Venner

Latest:

Master Protocols: Implementing Effective Treatment Adaptations in the Randomization

It is unrealistic to include infinite adaptations in an IRT system, thus identifying the optimal level of adaptations requires examination of the study’s characteristics and planning phase considerations.

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